Creatine Phosphokinase (CPK) Or Creatine Kinase (CK) is an enzyme found in various tissues, including muscles, brain, and heart. The Creatine Phosphokinase/Creatine Kinase Isoenzymes Test measures the levels of this enzyme in the blood to assess potential tissue damage. This test can help diagnose and monitor conditions related to muscle injury, heart attack, or other disorders.

Intended Use of Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System

A Creatine Phosphokinase/Creatine Kinase or Isoenzymes Test System is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.

Intended Use:

For the quantitative determination of creatine kinase activity in serum and plasma. Rx Only. Measurements of Creatine Kinase are used in the diagnosis and treatment of myocardial infarction and muscle disease, such as progressive Duchenne-type muscular dystrophy.

Device Description:

A Creatine Phosphokinase (CPK)/Creatine Kinase (CK) Isoenzymes Test System is a diagnostic tool designed to measure the levels of CPK and its isoenzymes in blood samples. This system typically includes specialized reagents and equipment for isolating and detecting the enzyme levels, particularly focusing on the three main isoenzymes—CK-MM, CK-MB, and CK-BB. The device often uses colorimetric, immunoassay, or enzymatic methods to quantify CPK levels, with each isoenzyme reflecting damage in different tissues like skeletal muscle, heart, or brain. The system is essential in laboratories for evaluating conditions such as heart attacks, muscle injuries, and neurological disorders by providing specific and sensitive measurement of CPK isoenzyme levels. The results are interpreted to determine the extent and location of tissue damage, helping healthcare providers diagnose and monitor these conditions effectively.

Differential Rate Kinetic Method, Cpk or Isoenzymes

Intended Use:

It is an in vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. The determination of CK and CK isoenzyme activities is utilized in the diagnosis and monitoring of myocardial infarction and myopathies such as the progressive Duchenne muscular dystrophy.

Device Description:

The differential rate kinetic method is a technique used to measure enzyme activity over time. Creatine Kinase (CK), also called CPK, is an enzyme important for muscle energy production, and its levels are measured to assess tissue damage, especially in muscle or heart injuries. Isoenzymes are different forms of the same enzyme, often tissue-specific, such as CK-MM, CK-MB, and CK-BB in creatine kinase. These isoenzymes can be identified using techniques like electrophoresis, which help pinpoint the source of enzyme activity. These devices are programmed to calculate enzyme activity based on the change in the reaction’s rate over time. The kinetic method can measure specific enzyme activities, such as CPK, by calculating the rate of reaction at various time intervals and the reaction’s slope.

U.V. Method, Cpk Isoenzymes (JHW)

Intended Use:

The intended use of the CK Reagent is for the quantitative in vitro diagnostic determination of creatine kinase (CK) levels in human serum and plasma. It is specifically designed to aid in the diagnosis and treatment of conditions like myocardial infarction (heart attack) and muscle diseases, such as progressive Duchenne-type muscular dystrophy. This is intended for use in laboratories or clinical environments equipped with the appropriate analytical systems.

Device Description:

The kinetic UV method for determining Creatine Kinase (CK) activity involves a coupled enzyme reaction where CK catalyzes the conversion of creatine phosphate and ADP to creatine and ATP. The ATP produced then drives a second reaction with D-glucose catalyzed by hexokinase to form D-glucose-6-phosphate (G-6-P). G-6-P is subsequently acted upon by glucose-6-phosphate dehydrogenase (G-6-PDH) in the presence of NADP+ to produce NADPH, which absorbs light at 340 nm. The increase in absorbance at 340 nm, measured by a spectrophotometer or automated analyzer, is directly proportional to CK activity. This method is sensitive, specific, and widely used in clinical diagnostics for conditions like myocardial infarction and muscle damage.

Fluorometric Method, Cpk or Isoenzymes

Intended Use:

It is an in vitro test for the quantitative determination of creatine kinase (CK) in human serum and plasma. The determination of CK and CK isoenzyme activities is utilized in the diagnosis and monitoring of myocardial infarction and myopathies such as the progressive Duchenne muscular dystrophy

Device Description:

Two assays are immunoassays designed to measure CK-MB levels in human serum and plasma, aiding in the diagnosis and treatment of conditions such as myocardial infarction and muscular diseases. The first assay utilizes a chemiluminescent immunoassay method where patient samples are mixed with antibodies and paramagnetic particles. The CK-MB in the sample binds to these antibodies, and the reaction generates light, which is measured to determine the concentration of CK-MB.The second assay uses an immunometric immunoassay approach, where CK-MB in the sample binds to a microwell coated with biotinylated antibodies. A labeled HRP antibody conjugate is then used to detect the binding through a luminescent reaction, where light production correlates to the amount of CK-MB in the sample. This method has been modified to minimize biotin interference and improve accuracy. Both assays rely on luminescence for detection, but they differ in their assay architecture and the strategies used to reduce interference for more reliable results.

Colorimetric Method, Cpk or Isoenzymes

Intended Use:

Immunoassay for the in vitro quantitative determination of the MB isoenzyme use of creatine kinase in human serum and plasma. Measurements of the MB isoenzyme of creatinine kinase are used as an aid in the diagnosis of myocardial infarction.

Device Description:

The CK-MB assay is a sandwich immunoassay that uses streptavidin microparticles and electrochemiluminescence detection to quantify the CK-MB isoenzyme in human serum or plasma. Results are determined through a calibration curve created via a 2-point calibration and a 5-point master curve provided with the reagent barcode. The assay has two versions: a one-step incubation, where all reagents are added at once, and a two-step incubation, which involves separate steps for reagent addition. Calibrators and controls are included to ensure accurate results. The one-step version simplifies the process, providing quicker results for myocardial infarction diagnosis.

Immunoassay Method, Troponin Subunit

Intended Use:

The intended use of the CK Reagent is for the quantitative in vitro diagnostic determination of creatine kinase (CK) levels in human serum and plasma. It is specifically designed to aid in the diagnosis and treatment of conditions like myocardial infarction (heart attack) and muscle diseases.

Device Description:

The test is a chemiluminescent enzyme immunoassay performed on the instrument to measure high-sensitivity cardiac troponin I (hs-cTnI-II) levels in patient samples. The test begins with the operator dispensing whole blood or plasma samples into a reagent cartridge, where they are combined with antibody-coated magnetic particles and alkaline phosphatase conjugates. The mixture is incubated at 37°C for 5 minutes, allowing the analyte to bind to the particles. Bound/Free separation is then performed using technology to remove excess reagents. A substrate is added, which is catalyzed by the bound alkaline phosphatase, emitting photons detected by the instrument’s photo-multiplier tube. These photons are converted into analyte concentration values based on a calibration curve. The test kit, which contains enough materials for 60 determinations, includes reagent cartridges, calibrators, and diluents, with additional calibration kits available separately.

• Stability Studies
• Precision/Reproducibility
• Detection studies
• Linearity/assay reportable range
• Detection limit
• Traceability (controls, calibrators, or method)
• Analytical Sensitivity
• Analytical Specificity (Cross-Reactivity)
• Interference

Clinical Testing:

No Guidance available for 510k submission